Lux receives US FDA complete response letter for uveitis drug
This article was originally published in Scrip
Lux Biosciences has received a complete response letter from the US FDA for Luveniq (oral voclosporin, LX211; licensed from Isotechnika Pharma), its treatment candidate for non-infectious uveitis. It requested that an additional clinical trial is conducted in order for an approval to be considered. Lux said it would conduct an additional pivotal study of Luveniq, which it expects to begin before the end of the year.